长沙招聘

Position Purpose
This Project/Report Coordinator role serves as the primary Submission Table and Workflow (STW) point of contact to some given Therapeutic Areas. This role works closely with other groups inside and outside Worldwide Safety and Regulatory (WSR) to coordinate the submission of US Aggregate Reports in compliance with governing SOPs and regulations.

? Project management for multiple reports simultaneously
? Coordinate contributions to include in reports and review/approval process with different function lines, including Safety, Clinical, Regulatory, Discovery etc.
? Generate tables from company database, perform QC and address issues in terms of data and format
? Contribute to continuous improvement activities based on understanding of aggregate reporting and expertise with the Pfizer corporate systems

Primary Responsibilities
? Monitors project timelines and ensures the different objects in adherence to required timeframes.
? Preparation of clinical trial and safety data tables related to submissions contributions include, but are not limited to, NDAs, IND ARs and IIR Line Listing.
? Plays a coordinator role representing STW in "Virtual Teams" aimed at ensuring optimum collaboration among different function lines to resolve any reporting issues.
? Evaluates current systems and processes and actively offers suggestions for systems and process improvements.
? Assists colleagues within and outside SER/MDL and WSR to support ad hoc data queries in support of aggregate reports.
? Ensures clear communication of project requirements to contributing groups
? Promotes consistency and standards with internal processes and deliverables.
? Supports Regulatory inspections and audits as appropriate.
? Performs QC reviews according to relevant SOPs and job aides
? May participate in system user acceptance testing (including script development and execution).
? May represent STW deliverables on divisional/internal task forces as a subject matter expert.



Qualifications (i.e., preferred education, experience, attributes)
? Bachelor required, biological, medical, or pharmaceutical sciences education desired.
? Experience in the pharmaceutical industry, or healthcare related field preferred.
? Experience in drug safety, medical information, or clinical research preferred.
? Knowledge of regulatory/safety regulations and guidelines desired.
? Knowledge of Safety reporting systems and technologies preferred
? Attention to detail and exceptional organizational skills
? Proficiency in English language (read, written and spoken)
? Track record of excellence in coordination skills
? Experience in project management preferred
? Experience in electronic document management preferred
? Experience in multinational company preferred

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。